Claims for Patent: 10,087,493

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Summary for Patent: 10,087,493

Title:	Method for detecting infectious parvovirus in pharmaceutical preparations
Abstract:	The present invention provides methods for detecting viral infectivity and content in an enzyme preparation. In certain embodiments, the invention relates to methods for producing a pharmaceutical pancreatic enzyme composition. In additional embodiments, the invention relates to detecting infectious porcine parvovirus (PPV) and determining PPV content in pancreatic enzyme preparations (PEPs), including pancrelipase preparations.
Inventor(s):	Tijssen; Peter (Pointe-Claire, CA), Szelei; Jozsef (Laval, CA), Zadori; Zoltan (Montreal, CA)
Assignee:	APTALIS PHARMA CANADA ULC (CA)
Application Number:	12/400,145
Patent Claims:	1. A method for producing a pharmaceutical product containing a pancreatic enzyme preparation having a porcine parvovirus (PPV) viral load below a threshold level comprising: a. obtaining a sample from a pancreatic enzyme preparation; b. detecting the load of porcine parvovirus in the sample comprising: i. extracting the sample at least two times with chloroform prior to precipitation producing a clarified sample with an upper phase and a lower phase; ii. precipitating an aliquot of the upper phase from step i) with polyethylene glycol (PEG); iii. suspending the product from step ii) in a buffer; iv. precipitating the product from step iii) with PEG; v. suspending the product from step iv) in an aqueous solution; vi. optionally extracting the product from step v) with chloroform producing a clarified sample with an upper phase and a lower phase; the upper phase forming a purified solution; and vii. determining the load of porcine parvovirus in the solution; and c. producing a pharmaceutical product with the remainder of the pancreatic enzyme preparation if the porcine parvovirus viral load measured in step b) is below a fluorescence focus infectious dose (FFID.sub.50) PPV viral load of about 10.sup.5 FFID.sub.50. 2. The method of claim 1, wherein the PEG is PEG 8000. 3. The method of claim 1, wherein the pancreatic enzyme composition is pancrelipase or pancreatine comprising various ratios of at least three enzymes selected from the group consisting of lipase, amylase, and protease.

Details for Patent 10,087,493

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	COTAZYM	pancrelipase	Capsule, Delayed Release	020580	December 09, 1996	10,087,493	2040-03-30
Abbvie Inc.	CREON	pancrelipase	Capsule, Delayed Release	020725	April 30, 2009	10,087,493	2040-03-30
Abbvie Inc.	CREON	pancrelipase	Capsule, Delayed Release	020725	June 10, 2011	10,087,493	2040-03-30
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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